Although transcatheter arterial chemoembolization (TACE) is considered to be an effective treatment for advanced hepatocellular carcinoma (HCC), it is difficult to achieve complete necrosis by TACE alone due to incomplete embolization and tumor angiogenesis. Recent studies have shown that tegafur/uracil (UFT®) inhibits tumor angiogenesis in several cancer types. Therefore, this study was conducted to test the efficacy and toxicity of the UFT administration after TACE in advanced HCC. Thirty patients with HCC who had been treated with TACE alone more than three times and had a recurrence within 6 months were enrolled. All of the patients were treated with TACE and 28 patients were randomly assigned to the UFT (UFT 300 mg/day, three days after TACE, n=14) and control groups (n=14). The primary end point was the time to treatment failure (TTF) and the secondary end points were mainly the response rate and toxicity. Administration and observation were continued up to 6 months after TACE unless local recurrence was detected or serious adverse events developed. The median TTF in the control group was 87 days, whereas in the UFT group it was 127 days, thus significantly prolonged as compared to the control group (P=0.0016). Moreover, the overall response rate (35.7%) in the UFT group was significantly higher than that in the control group (0%). As for toxicity, only 4 patients in the UFT group developed grade 1-2 toxicities such as ascites. Serious complications by TACE were not observed in either group. Notably, there were no increases in the serum VEGF levels in the UFT group whereas those in the control group increased significantly. In conclusion, UFT administration after TACE was an effective treatment and showed no severe adverse events. This regimen may have an adjuvant role and antiangiogenic function in advanced HCC.

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